TBI (traumatic brain injury) is a traumatic insult to the brain from an external mechanical force, such as a car accident, a fall or an explosion. The injury can lead to permanent or temporary impairments of cognitive, physical and psychosocial functions with an associated diminished or altered state of consciousness. An estimated 1.7 million Americans per year suffer a TBI, resulting in 52,000 deaths, 275,000 hospitalizations and 80,000 cases of long-term disability.It is also the leading cause of death and disability in children and young adults worldwide, TBI is involved in nearly half of all trauma deaths. Traffic accidents account for 40-50 percent of the hospitalizations related to the condition.The annual incidence of TBI is higher than breast cancer and HIV/AIDS combined, yet it is largely ignored.

PROGESTERONE GIVEN WITHIN 4 HOURS FROM INJURY TESTEDThe ProTECT study will determine if intravenous (IV) progesterone (started within 4 hours of injury and given for a total of 96 hours), is more effective than placebo for treating victims of moderate to severe acute traumatic brain injury.Trial no: NCT00822900The new three-to-six-year trial, which is known as proTECT III will be led by David Wright, MD, associate professor of emergency medicine at Emory University School of Medicine. Atlanta’s Grady Memorial Hospital has been designated the lead center.

The possible introduction of progesterone as treatment for brain injured patients will be most welcome by the medical community, as there have been no effective treatments for such injuries.

Progesterone, a hormone that has a role in female fertility, it also seem to protect brain cells in brain injured patients.

This large-scale trial, which will involve hospitals in 15 states, was prompted by findings from several previous studies, including a recent small study in which investigators found that administering progesterone soon after a brain injury reduced the death rate by 50 percent and improved the patients’ ability to recover.

Another earlier study conducted at Zhejiang University in China two years ago found that patients with serious brain injuries who were given progesterone were more likely to survive than those who received a placebo. Among the patients who survived, those who had received progesterone had made a good recovery at six months after treatment (58% of patients) compared with those who had received placebo (42% of patients).

In the new trial, hospitals will randomly assign 1,140 patients who arrive for emergency care within 11 hours of their brain injury to receive either three days of infusion treatments with progesterone or placebo. Because it appears the infusions are most effective if given within 11 hours of a patient’s injury, it may not always be possible to obtain consent from next of kin for a patient to take part in the trial. The Food and Drug Administration has drawn up special rules to allow trials that involve emergency medical treatments to proceed without consent.

Another trial called SyNAPSe Phase 3 will study if giving intravenous (i.v.) progesterone within 8 hours of the injury for a total of 120 hours to severe traumatic brain injury patients improves their recovery.Trial no: NCT01143064 and it is conducted by BHR Pharma, LLC."This drug has the potential to help a gravely ill population that includes car crash and battlefield injuries and we could not be more pleased to initiate this important trial," said Tom MacAllister, J.D., Ph.D., BHR president and CEO. "The annual incidence of TBI is higher than breast cancer and HIV/AIDS combined, yet it is largely ignored. We are proud to lead the efforts to make a difference for these patients and their families."

Currently, the lack of water solubility limits delivery of progesterone, in that the hormone must be prepared hours ahead and cannot be kept at room temperature. Small chemical modifications may allow similar compounds with the same effects as progesterone to be given to patients closer to the time of injury.

Another idea is that adding vitamin D to progesterone enhances the hormone’s effectiveness when applied to neurons under stress in the laboratory. Like progesterone, vitamin D is a steroid hormone that is inexpensive, has good safety properties and acts on many different biochemical pathways.BHR Pharma is a wholly owned subsidiary of Besins Healthcare SA, which markets healthcare products in 93 countries.